Fresh from Qalsody’s success, Biogen is keeping its eye on whether a candidate from NeuroSense Therapeutics could prove to be a hit against the same biomarker—and maybe become the next addition to the Big Pharma’s amyotrophic lateral sclerosis (ALS) portfolio.
NeuroSense is currently running a phase 2b trial of PrimeC—a formulation of the antibiotic ciprofloxacin and the nonsteroidal anti-inflammatory drug celecoxib—in ALS. The Israeli company revealed in a Securities and Exchange Commission filing yesterday that it has entered into an agreement for Biogen to assess PrimeC’s impact on neurofilaments, for which elevated levels are considered a biomarker for ALS.
The biotech will provide Biogen with blood samples from 69 trial patients, which will be used for a biomarker analysis study to be funded by the Big Pharma. NeuroSense will also keep Biogen updated with the patients’ clinical outcomes along with the results from other biomarkers being assessed.
If Biogen likes what it sees, if may go in deeper. The agreement gives Biogen the right of first refusal to co-develop and co-commercialize PrimeC as part of a licensing deal.
Biogen has had some success in the ALS arena recently, courtesy of the FDA’s conditional approval of Qalsody in April. It followed an FDA advisory committee recommendation that Qalsody’s ability to reduce neurofilament levels provided enough basis for the approval in patients with ALS associated with a mutation in the SOD1 gene.
The FDA green light marked a “consensus that neurofilament can be used as a surrogate marker reasonably likely to predict clinical benefit in SOD1-ALS,” Biogen CEO Chris Viehbacher said at the time.
Qalsody’s nod comes seven months after the FDA’s approval for Amylyx’s Relyvrio, but this year has also brought reminders of why ALS remains such a tricky indication. In March, Cytokinetics’ reldesemtiv flunked a phase 3 trial, followed a month later by Wave Life Sciences, which gave up on its antisense oligonucleotide after getting a peek at early-phase data in ALS and frontotemporal dementia.